drugset / Trial / NCT02408523
A Study to Assess the Safety and Efficacy of Lacosamide Versus Placebo (a Pill Without Active Medication) in Patients With Idiopathic Generalised Epilepsy Who Are Already Taking Anti-epileptic Medications
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Evaluating efficacy \& safety of lacosamide versus Placebo in a blinded fashion as add-on Therapy for Primary Generalized Tonic-clonic (PGTC) seizures in subject 4 years of age or greater with idiopathic generalized epilepsy currently taking 1 to 3 antiepileptic drugs. Maximum duration of study drug administration is 28 weeks. Eligible subjects may choose to enter the open-label extension study after completion.
Timeline
- Start
- 2015-04
- Primary completion
- 2019-04
- Completion
- 2019-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lacosamide | Other / unclassified | 8 mg/kg | Oral |
| Subject | Lacosamide | Other / unclassified | 12 mg/kg | Oral |
| Subject | Lacosamide | Other / unclassified | 400 mg | Oral |